BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 4483657 · Received February 4, 2015

    Report

    Report Number
    1644487-2015-03749
    Event Type
    Injury
    Date Received
    February 4, 2015
    Date of Event
    January 6, 2015
    Report Date
    January 9, 2015
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT EXPERIENCED A DROP ATTACK AND BLACKED OUT FOLLOWING A MAGNET SWIPE. IT WAS NOTED THAT THIS SEIZURE TYPE WAS NOT TYPICAL FOR THE PATIENT. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S REPORTED EPISODE IS NOT A NEW SEIZURE TYPE, UNKNOWN CAUSE FOR EPISODE (DROP ATTACK WITH LIPS TURNING BLUE). NO INTERVENTIONS WERE TAKEN. MEDICATIONS TAKING AT THE TIME OF THE EVENT. DEPAKOTE-6.25 MG BID / FYCOMPA 8 MG QHS / ZONISAMIDE-150 MG QHS / BANZEL 17.5 ML IN AM, 3.5 ML IN AFTERNOON , 7 ML EVENING / ONFI-5 MG BID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79934 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS INC 103 3546

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Other